SQA-iO Sperm Quality Analyzer— 510(k) K220828

Substantially Equivalent

Medical Electronic Systems , Ltd.

FDA 510(k) clearance K220828 for SQA-iO Sperm Quality Analyzer, Substantially Equivalent on 2023-08-07. Applicant: Medical Electronic Systems , Ltd..

Clearance details

Applicant: Medical Electronic Systems , Ltd.
Product code: Code POV
Advisory panel: Hematology
Date received: 2022-03-22
Decision date: 2023-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

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